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Myriad Matrix™ Soft Tissue Bioscaffold

FDA UDI

Class U (US FDA UDI)

by Aroa Biosurgery

Identity

Trade Name
Myriad Matrix™ Soft Tissue Bioscaffold FDA UDI
Generic Name
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Device Name
Myriad Matrix™ is an intact extracelluar matrix (ECM) derived from ovine (sheep) forestomach tissue. This advanced ECM scaffold is non-reconstituted collagen, thus it retains the innate biological structure and function of the native ECM associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. Myriad Matrix transforms into a soft conforming sheet, which is incorporated into the surrounding tissue over time. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed to size or applied whole to meet the individual patient's needs. FDA UDI
Model / Reference
SR05LG0505US FDA UDI
Description
Myriad Matrix™ is an intact extracelluar matrix (ECM) derived from ovine (sheep) forestomach tissue. This advanced ECM scaffold is non-reconstituted collagen, thus it retains the innate biological structure and function of the native ECM associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. Myriad Matrix transforms into a soft conforming sheet, which is incorporated into the surrounding tissue over time. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed to size or applied whole to meet the individual patient's needs. FDA UDI

Identifiers

Primary DI / UDI-DI
09421906017625 FDA UDI
510(k) Number
K162461 FDA UDI
K171231 FDA UDI
FDA Product Code
KGN FDA UDI
FTM FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Animal-derived wound matrix dressingExtra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Myriad Matrix™ Soft Tissue Bioscaffold by Aroa Biosurgery — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.

Cleared under the same submission

K162461 also covers:

K171231 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aroa Biosurgery

Sources (1)

  • FDA UDI 16335860-0099-4083-ab24-2398b97aefb8 36 fields · synced May 29, 2026